Immunological Memory Against Pneumococcus Induced by 3 Infant PCV 13 Vaccination Schedules

• Conditions: Immunogenicity, Vaccine; Immunologic Memory

• Registration Number: NCT03405805
• Lead Sponsor: Aghia Sophia Children's Hospital of Athens

Brief Summary

The purpose of this study is to evaluate the establishment of immunological memory between the 3 different infant vaccination schedules with the 13-valent pneumococcal conjugate vaccine (PCV13) currently in use. We aim to determine the optimal schedule for the establishment of antigen-specific memory B-cell pool, which may serve as a correlate for longevity of immunological memory against vaccine serotypes. Moreover, we will study the transcriptome profiles expressed by peripheral lymphocytes during each immune response in an attempt to reveal immunological mechanisms beyond the antibody and circulating B cells level.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-12
• Status Verified: 2018-01
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Last Update Submitted: 2018-01-15
• Study First Posted: 2018-01-23
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 2-15 months of age

Exclusion Criteria

• previously recorded allergy to PCV
• intravenous immunoglobulin (IVIG) given within the previous 6 months
• primary or secondary immunodeficiency
• any chronic medical condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
switched immunoglobulin G (swIgG) B memory cell response (measured by flow cytometry)	28 days post last vaccine dose	phenotype characterisation of swIgG memory B cells pre- and post- last dose of PCV13
immunoglobulin G (IgG) antibody serum titers (measured by ELISA)	28 days post last vaccine dose	measurement of IgG antibody titers in serum pre- and post- last dose of PCV13
immunoglobulin M (IgM) B memory cell response (measured by flow cytometry)	28 days post last vaccine dose	phenotype characterisation of IgM memory B cells pre- and post- last dose of PCV13

Secondary Outcome Measures

Name	Time	Method
Transcriptional profile of Peripheral Blood Mononuclear Cells (PBMC) in response to PCV13 (measured by RNA-Sequencing)	7 days post last vaccine dose	transcriptome analysis of PBMCs pre- and post last dose of PCV13 on a cohort of patients

Trial Locations

Locations (1)

'Aghia Sophia' Children's Hospital; 🇬🇷 Athens, Attiki, Greece